# China NMPA Product Recall - Digital angiography system / Digital angiography imaging system / Cardiovascular imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/1ed1a0d8-7c91-4928-89f6-cefd74664f8f/
Source feed: China

> China NMPA product recall for Digital angiography system / Digital angiography imaging system / Cardiovascular imaging system by GE Healthcare (China) Co., Ltd. published October 08, 2011. Recall level: . GE Healthcare initiated a voluntary recall for several models of its digital angiography and cardiov

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare recalls all-digital angiography systems/all-digital angiography imaging systems/cardiovascular imaging systems
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2011-10-08
- Product Name: Digital angiography system / Digital angiography imaging system / Cardiovascular imaging system
- Recall Reason: The X-ray dosimetry system (M4-KDK) is an accessory for the Innova system. This accessory does not comply with the requirements of the U.S. Federal Regulation 21 CFR 1020.30. After installing this accessory, X-ray dose information cannot be displayed on the Innova system monitor.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare initiated a voluntary recall for several models of its digital angiography and cardiovascular imaging systems, including various Innova series (e.g., Innova3100, Innova2100IQ, Innova3100IQ). This action, reported to the National Medical Products Administration (NMPA) around September 20, 2011, stemmed from a critical issue with the X-ray dosimetry system (M4-KDK) accessory. The component failed to comply with specific US federal regulations (21 CFR 1020.30), rendering it unable to display essential X-ray dose information on the Innova system monitors after installation. While the recall originated due to non-compliance with US standards, GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. clarified that the Chinese market was not impacted. Despite this, provincial and municipal regulatory authorities in China were urged to enhance their supervision of such medical devices. The company's required corrective actions involve issuing formal recall notices to all affected users and dispatching service engineers to perform on-site repairs for every Innova system equipped with the non-compliant M4-KDK component. This ensures compliance and restores critical dose information display capabilities for patient safety.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/